The Advanced Medical Technology Association (AdvaMed) and diagnostic test manufacturers, labs, health care nonprofits and industry associations are asking federal lawmakers to pass diagnostics regulations as part of the FDA Safety and Landmark Advancements (FDASLA) Act of 2022.
The proposed diagnostic test regulations — outlined in the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — would increase FDA’s oversight of laboratory-developed tests (LDTs), treating them more like medical devices with a risk-based approach. The VALID Act would require pre-market review for diagnostic tests that have a high risk of serious injury or death due to treatment decisions based on inaccurate results.
“The current federal approach to oversight has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for improved patient outcomes,” AdvaMed’s letter said. “As Congress finalizes a legislative package reauthorizing FDA’s user fee programs, it can also seize this truly unique opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests.”
The changes could prevent the likelihood of a future Theranos-like company exploiting FDA loopholes. However, groups like the American Society for Clinical Pathology say the many potential ramifications of the VALID Act warrant consideration separate from the FDASLA Act and the FDA funding within it, including the latest version of the Medical Device User Fee Amendments (MDUFA).
“Rather than being regulated under the Clinical Laboratory Improvement Amendments of 1988, as is currently the case, the VALID Act could subject these tests to the same regulatory requirements as commercial diagnostics,” ASCP said in a statement. “This would expose LDTs to expensive approval fees, pre-market approval, and other regulatory requirements — a possibility that would deter many clinical laboratories from developing and offering these innovative and critical diagnostics to their patients.”